Estimation of clinical trial success rates and related parameters

Biostatistics

Volumn 20, Issue 2, 2019, Pages 273-286

  Wong, Chi Heem ^a   Siah, Kien Wei ^a   Lo, Andrew W ^b  

^a MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^b AlphaSimplex Group LLC   (United States)

Author keywords

Clinical phase transition probabilities; Clinical trial statistics; Probabilities of success

Indexed keywords

BIOLOGICAL MARKER;

CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; FACTUAL DATABASE; HUMAN; OUTCOME ASSESSMENT; PROCEDURES; STATISTICAL MODEL;

BIOMARKERS; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; DRUG DEVELOPMENT; HUMANS; MODELS, STATISTICAL; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 85059547194     PISSN: 14654644     EISSN: 14684357     Source Type: Journal    
DOI: 10.1093/biostatistics/kxx069     Document Type: Article

References (10)

1. ABRANTES-METZ, R. M., ADAMS, C. AND METZ, A. D. (2005). Pharmaceutical development phases: A duration analysis. Journal of Pharmaceutical Finance, Economics and Policy 14, 19-42.
2. DANZON, P. M., NICHOLSON, S. AND PEREIRA, N. S. (2005). Productivity in pharmaceutical-biotechnology R&D: The role of experience and alliances. Journal of Health Economics 24, 317-339.
3. DIMASI, J. A., FELDMAN, L., SECKLER, A. AND WILSON, A. (2010). Trends in risks associated with new drug development: success rates for investigational drugs. Clinical Pharmacology and Therapeutics 87, 272-277.
4. HAY, M., THOMAS, D. W., CRAIGHEAD, J. L., ECONOMIDES, C. AND ROSENTHAL, J. (2014). Clinical development success rates for investigational drugs. Nature Biotechnology 32, 40-51.
5. MALEC, P. AND SCHIENLE, M. (2014). Nonparametric kernel density estimation near the boundary. Computational Statistics & Data Analysis 72, 57-76.
6. MARTIN, L., HUTCHENS, M. AND HAWKINS, C. (2017). Trial watch: clinical trial cycle times continue to increase despite industry efforts. Nature Reviews Drug Discovery 16, 157.
7. ROOT, C. (2014). Biogen IdecMovesAggressively, AdvancesAlzheimer Drug into Phase 3. https://www.clinicalleader.com/doc/biogen-idec-movesaggressively-Advances-Alzheimer-drug-into-phase-0001.
8. SMIETANA, K., SIATKOWSKI, M. AND MØLLER, M. (2016). Trends in clinical success rates. Nature Reviews Drug Discovery 15, 379-380.
9. THOMAS, D.W, BURNS, J., AUDETTE, J., CARROL, A., DOW-HYGELUND, C.ANDHAY, M. (2016). Clinical Development Success Rates 2006-2015. San Diego: Biomedtracker.
10. U.S. FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH. (2016). Novel Drugs Summary 2015. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm.